RFP Announcement: International Clinical Sciences Support - NIH-NIAID-DMID-05-07

Notice Number: NOT-AI-04-053

Key Dates
Release Date: September 3, 2004
Receipt Date: November 15, 2004

Issued by
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)

Description

The Division of Microbiology and Infectious Diseases (DMID), of the National Institute of Allergy and Infectious Diseases (NIAID), of the National Institutes of Health (NIH), intends to compete a requirement currently being performed by Family Health International (FHI) under Contract No. N01-AI-05403. This solicitation is being issued under full and open competitive procedures. DMID supports extramural research to diagnose, treat, and prevent diseases caused by virtually all human infectious agents except HIV. DMID supports projects spanning the entire spectrum of biomedical research from early basic research through phase III clinical trials. Through the contemplated contract, DMID intends to establish and maintain an International Clinical Studies Support Center (ICSSC). The primary goal of the ICSSC is to enhance the capacity of international clinical sites to perform clinical research in accordance with international standards, such as the International Conference on Harmonization’s (ICH) Good Clinical Practices (GCP), and to facilitate the planning and conduct of clinical evaluations of interventions against infectious disease. Studies that require support include epidemiologic studies and clinical trials that range from small, early phase trials to large multi-center efficacy trials. These studies are conducted throughout the world, primarily in Africa, South and Central America, and Asia. The primary focus of this solicitation is assistance and site development activities rather than regulatory compliance or monitoring activities as these services are provided under other DMID-funded contracts. The activities of all concerned contractors will be coordinated by DMID staff. Work to be performed will include: assessment of the readiness of sites to conduct clinical studies; development and design of clinical protocols; training in clinical research design and conduct, including GCP and ethical issues, data management, statistical analysis, and safety monitoring and; logistical/operational aspects of managing the DMID international clinical research portfolio. It is anticipated that the resultant contract will require an estimated 4 FTEs with expertise consistent with the operations of a project of this size and complexity. Any responsible offeror may submit a proposal that will be considered by the Government. This notice does not commit the Government to award of a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26.

It is anticipated that up to one award for a cost reimbursement, completion type contract will be awarded for a period of seven (7) years, beginning approximately July 20, 2005. RFP NIH-NIAID-DMID-05-07 will be available electronically on or about September 15, 2004, and may be accessed at http://www.niaid.nih.gov/contract/rfps.htm or http://www.fedbizopps.gov/. Only electronic copies of the solicitation will be available. All information required for the submission of an offer will be contained in the solicitation. Responses to this RFP will be due on/before November 11, 2004.

Any responsible offeror may submit a proposal that will be considered by the Government, however, this notice does not commit the Government to the award of a contract. No collect calls will be accepted.

Contracting Office Address

Department of Health and Human Services
National Institutes of Health
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Contract Management Program
6700-B Rockledge Drive
Room 3214, MSC 7612
Bethesda, MD 20892-7612

Point of Contact

David Lisle, Contract Specialist, Phone 301-451-2617, Fax 301-402-0972, Email dlisle@niaid.nih.gov
Barbara Shadrick, Contracting Officer, Phone 301-496-7288, Fax 301-402-0972, Email bs92y@nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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